Evaluating Trogocytosis as a Predictor for CAR-T Cell Therapy Success in Lymphoma
La Trogocytose Est-elle un Marqueur prédictif de la réponse Aux Cellules CAR-T Dans Les Lymphomes Diffus à Grandes Cellules B ?
This study is testing if measuring a process called trogocytosis in immune cells can help predict how well CAR-T cell therapy works for people with lymphoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | CART, CAR-T, Chimeric Antigen Receptor |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT06352242 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of trogocytosis, a process where immune cells acquire fragments of tumor cell membranes, as a potential predictive marker for the response to CAR-T cell therapy in patients with diffuse large B-cell lymphoma (DLBCL). By analyzing the level of trogocytosis in immune effector cells before and after CAR-T cell infusion, researchers aim to establish a correlation between these levels and patient outcomes at six months post-treatment. The study includes both patients undergoing CAR-T therapy and healthy volunteers for comparative analysis using flow cytometry techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with relapsed or refractory diffuse large B-cell lymphoma who are scheduled to receive anti-CD19 CAR-T cell therapy.
Not a fit: Patients who are pregnant, breastfeeding, or unable to comply with the study procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a predictive test that helps identify which patients are likely to benefit from CAR-T cell therapy, potentially improving treatment outcomes.
How similar studies have performed: While the concept of using trogocytosis as a predictive marker is relatively novel, previous studies have shown promising correlations between immune cell behavior and treatment outcomes in hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For patients * Patient who has given free and informed consent in writing for inclusion in the non-interventional CART-BANK protocol, and orally for the CARTROG protocol, * Patients over 18 years of age at the time of inclusion, * Diagnosis of LDGCB, * Decision to treat with anti-CD19 CAR-T cells, * Patient affiliated to or benefiting from a social security scheme. * For healthy volunteers: * Given free and informed oral consent for inclusion in the CARTROG protocol, * Donor between 18 and 70 years of age at the time of inclusion, * No history of solid cancer or hematological malignancy, * No known chronic pathology (e.g. hypertension, diabetes, etc.) and no daily treatment, * No surgical treatment within the last 6 months. Exclusion Criteria: * Patients who do not meet all the inclusion criteria, * Pregnant or breast-feeding patient, * Patient unable to follow the procedures and/or frequency of visits planned in the trial, for psychological, family, social or geographical reasons, * Patient unable to consent freely to inclusion, under guardianship, curatorship or safeguard of justice.
Where this trial is running
Montpellier and 1 other locations
- Clinical hematology department, University Hospital — Montpellier, France (Recruiting)
- Clinical Investigation Center, University Hospital — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Ludovic GABELLIER, MD — Montpellier University Hospital
- Study coordinator: Valérie ROUILLE
- Email: v-rouille@chu-montpellier.fr
- Phone: +33467332645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.